Aimmune’s peanut allergy candidate hits main endpoint at Phase 3
pharmafile | February 21, 2018 | News story | Research and Development | Aimmune, peanut, peanut allergy, pharma
US biopharmaceutical firm Aimmune has revealed that its peanut allergy candidate AR101 hit its primary endpoint in the largest trial of its kind, proving that around two-thirds of patients were are able to tolerate at least 600mg of peanut protein – equal to about two average peanut kernels – after taking the drug.
The candidate was tested in 496 patients between the ages of 4 and 17, who were evaluated with an exit double-blind, placebo-controlled food challenge on entering the trial and after approximately one year of taking the drug. It was found that 67.2% were able to tolerate a single highest dose of at least 600mg of peanut protein with no more than mild symptoms, compared to just 4% of those taking placebo. Furthermore, 50.3% of patients were able to tolerate a single highest dose of 1000mg off peanut protein, compared to 2.4% of placebo patients.
These endpoint evaluations were carried out by independent, blinded assessors to minimise the risk of assessment bias.
To put these findings into perspective, these patients in the primary analysis group were able to tolerate no more than 30mg on entering the trial, while 72.2% had a history of anaphylaxis, 65.5% reported multiple food allergies, and 53% had a present or previous diagnosis of asthma.
“PALISADE is not only the largest peanut allergy trial ever conducted, it’s also the first to use an independent blinded assessor, and the first to accept peanut-allergic patients with a history of severe or life-threatening reactions. Moreover, the PALISADE population was highly peanut-sensitive and highly atopic, with almost three quarters of the patients having experienced anaphylaxis prior to enrolling in the study,” commented said Dr Daniel C Adelman, Chief Medical Officer of Aimmune. “Given how robust the PALISADE results are and that they met or exceeded the pre-specified metrics, we’re very encouraged that the data from PALISADE are helping to define the magnitude of the potential treatment effect in very sensitive peanut-allergic patients.”
There is currently no treatment for peanut allergy, the prevalence of which doubled between 1997 and 2008, and today affects around 2% of American children. Aimmune aims to file for regulatory approval of AR101 at the end of 2018 in the US and the first half of 2019 in Europe.
Matt Fellows
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